BRIEFING

 〈41〉 Balances. This proposal is based on the version of the chapter official as of August 1, 2019. On the basis of comments received from stakeholders and to align with USP Weighing on an Analytical Balance 〈1251〉 and the Balances chapter in the European Pharmacopoeia, it is proposed to make the following changes to this general chapter:

1. Introduce the relationship among calibration and performance checks with the life cycle approach to ensure fitness for purpose.

2. Include the concept of the risk-based approach with respect to the frequency of calibration and performance checks.

3. Add a new section for Calibration, clarifying its purpose and considerations for uncertainty and frequency.

4. Introduce clarifications for compliance with respect to the repeatability test.

5. Minimum weight is aligned with that in 〈1251〉 and the European Pharmacopoeia with regards to the standard deviation. Examples of calculation have been introduced.

6. A clarification note has been introduced to differentiate minimum weight from the smallest net weight.

7. Clarifications of criteria are stated to comply with the accuracy during the performance test and calibration, including the uncertainty of the test weights.

8. Additional applicable references have been incorporated into the text.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCMDQ: A. Hernandez-Cardoso)

 Correspondence Number—C323006